JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer

NCT04951947 · tracked via the Priya Life Science China tracker

Sponsor

Hunan Province Tumor Hospital

Phase

Phase 2

Started

2023-06-01

Last updated

2024-09-19

Condition(s) studied

Small-cell Lung Cancer

Investigational drug(s) / intervention(s)

JS201 combine with Lenvatinib

JS201 combine with Lenvatinib: JS201 300mg i.v Q2wLenvatinib 8mg po. Qd

Study summary

This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 1\. The imaging diagnosis is the extensive stage of SCLC * 2\. The patient failed first-line EC+PD-L1 treatment * 3 PS 0-1 Exclusion Criteria: * 1\. Diagnosed as non-small cell lung cancer * 2\. Women during pregnancy * 3\. Patients with symptomatic brain metastases * 4\. PS≥2

Primary outcome measure(s)

ORR — 1 year
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

Trial sites (1)

Facility	City	Region	Status
Hunan Cancer Hospital	Changsha	Hunan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04951947 on ClinicalTrials.gov ↗ ← All trials in China